Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

Conditions

• Metastatic Ewing Sarcoma

Eligibility Criteria

Sex

ALL

Age

1 Year - N/A

Healthy Volunteers

Not accepted

Interventions

• Vincristine — DRUG
  IV Push
• Doxorubicin — DRUG
  IV
• Cyclophosphamide — DRUG
  IV and Maintenance PO
• Ifosfamide — DRUG
  IV
• Actinomycin — DRUG
  IV
• Irinotecan — DRUG
  IV
• Cabozantinib — DRUG
  PO
• Topotecan — DRUG
  IV
• Temozolomide — DRUG
  IV
• Etoposide — DRUG
  PO
• Liposomal doxorubicin — DRUG
  IV

Study Details

This single arm study is designed to demonstrate the feasibility of a radically different approach for an exceptionally high-risk subset of MES with widely metastatic disease (WMES). We incorporate the use of evolutionary principles that apply to species and population dynamics as related to adaptation and extinction to populations of cancer cells that similarly adapt and that we are attempting to make extinct, resulting in a cure for the patient. Such principles include an initial intense first strike to deplete the bulk of the cancer cells, followed by a series of sequential second strikes towards eliminating residual, resistant populations, followed by a prolonged period of maintenance chemotherapy to eliminate any remnant cells, using agents generally regarded to be active against newly diagnosed ES.

Key Dates

Start date

Feb 5, 2026

Status verified

May 2026

Primary completion

Oct 31, 2030

Completion

Oct 31, 2030

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Sequential Therapy
  Weeks 1-8, Vincristine/Doxorubicin/Cyclophosphamide. Weeks 9-14, Irinotecan, Ifosfamide, Vincristine, Actinomycin (IrIVA). Weeks 15-20, Cabozantinib w/ primary site radiation. Weeks 21-26, Topotecan/Cyclophosphamide. Weeks 27-32, High Dose Ifosfamide. Weeks 33-38, Irinotecan/Temozolomide. Maintenance, Weeks 39 up to 104, will consist of alternating 28-day blocks of chemotherapy (Block 1 and Block 2). Oral Cyclophosphamide / Oral Etoposide (Block 1). Vincristine/ Liposomal Doxorubicin (Block 2).

Primary Outcome Measure

Feasibility and Safety - Consolidation [ Time Frame: 16 months ]

Central Contacts

• Jessica Crimella
  813-745-6250
  [email protected]

Locations (17)

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